CLASS I Drug recall · Reported 29 Nov 2023 · FDA Enforcement Report
Polyvinyl Alcohol 4% Lubricating Eye Drops recalled
The Harvard Drug Group is recalling Polyvinyl Alcohol 4% Lubricating Eye Drops, distributed nationwide in the US. The recall was initiated on 31 Oct 2023 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0107-2024
- FDA event ID
- 93339
- Recalling firm
- The Harvard Drug Group, La Vergne, TN
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 31 Oct 2023
- FDA classified
- 17 Nov 2023
- Reported
- 29 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 31 Oct 2023 | Recall initiated by company | |
| 17 Nov 2023 | Classified by FDA | +17 days |
| 29 Nov 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Polyvinyl Alcohol 4% Lubricating Eye Drops recalled?
Yes. The Harvard Drug Group recalled Polyvinyl Alcohol 4% Lubricating Eye Drops on 31 Oct 2023. The recall is Class I and its status is Terminated. Recall number D-0107-2024.
Why was it recalled?
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Which lots are affected?
All lots
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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